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We are pleased to announce that as of today, Purple Vigilance is able to offer a new service; we can now assist Marketing Authorisation Holders (MAHs) and Sponsors with data entry and maintenance of products details in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).

Background on the XEVMPD

One of the key deliverables of the 2010 Pharmacovigilance legislation relates to the submission by MAHs of information about medicines to the European Medicines Agency (EMA). The requirement is described in Article 57(2) of Regulation (EC) No 1235/2010.

It requires:

MAHs to submit information to the EMA electronically on all medicinal products for human use authorised in the European Union by 2 July 2012, using this format;

MAHs to inform the EMA of any new or varied marketing authorisations granted in the EU as of 2 July 2012, using this format.

Purple Vigilance can enter the details of your products onto XEVMPD and provide on-going maintenance to ensure continued compliance.

Purple Vigilance is 1 year old! It’s been a year since Purple Vigilance was incorporated and what an eventful year it has been. 2012 has seen the implementation of biggest change in EU Pharmacovigilance (PV) legislation and regulation of human medicines in the European Union since 1995.

Purple Vigilance has completed a wide range of projects in the last year, from training on the new legislation to preparing templates for common PV documents. Purple Vigilance is providing on-going PV support to several companies in addition to EU QPPV services.

I would like to thank all of Purple Vigilance’s clients for your business and kind support over the last year – you have helped the business to be a success!

If your organisation has any PV needs, however small, please do not hesitate to contact us for advice.

Purple Vigilance joins the EMA in welcoming the start of new European Union legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines. The new pharmacovigilance legislation is comprised of Directive 2010/84/EU and Regulation (EU) No 1235/2010. A key deliverable for the new legislation was the release of a set of Good Pharmacovigilance Practice (GVP) modules.

On 25 June the EMA published the first set of finalised GVP documents that had been released for public consultation earlier this year. The finalised modules released are as follows:

The European Medicines Agency (EMA) has published a further Q and A document on the practical transitional measures for implementation of the new PV legislation.

The document provides information on areas such as the ADR reporting, PSURs, pharmacovigilance system master file, risk management plans and PASS in the period of transition from Volume 9a to the new legislation. A must-read for all Marketing Authorisation Holders!

The EMA has published a Q and A document on transitional arrangements for the new pharmacovigilance legislation in preparation for July 2012.

The document addresses some of the questions that Marketing Authorisation Holders may have on areas such as the pharmacovigilance system master file, risk management plans and the submission of renewals.

The European Medicines Agency have today released seven of the long awaited good pharmacovigilance practice (GVP) modules for consultation. The modules outline the practical implementation of the new PV legislation that will apply from July 2012, and will make essential reading for all Marketing Authorisation Holders and other interested parties. The remaining nine modules are being developed and will be released later in 2012.